FDA.reportPublic FDA data

Etchmaster

Primary DI
00817494020021
Brand
Etchmaster
Company
GROMAN INC.
Model
EM-S-K-RB
Catalog number
EM-S-K-RB
Device description
EtchMaster® disposable Small microetching tip pre-filled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular bend nozzle,
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030292000GROMAN PREPMASTERGroman, Inc.2003-04-15KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817494020028PackageGS12In Commercial Distribution
11817494020027PackageGS150In Commercial Distribution
12817494020027PackageGS116In Commercial Distribution
13817494020027PackageGS125In Commercial Distribution
20817494020025PackageGS15In Commercial Distribution
30817494020022PackageGS18In Commercial Distribution
40817494020029PackageGS125In Commercial Distribution
50817494020026PackageGS150In Commercial Distribution
60817494020023PackageGS1100In Commercial Distribution
70817494020020PackageGS132In Commercial Distribution
80817494020027PackageGS150In Commercial Distribution
90817494020024PackageGS132In Commercial Distribution
00817494020021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749402002810817494020028
1181749402002711817494020027
1281749402002712817494020027
1381749402002713817494020027
2081749402002520817494020025
3081749402002230817494020022
4081749402002940817494020029
5081749402002650817494020026
6081749402002360817494020023
7081749402002070817494020020
8081749402002780817494020027
9081749402002490817494020024
00817494020021008174940200218174940200210817494020021

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet systemAn assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Contacts#

Phone, Email table
PhoneEmail
800-906-9298Customerservice@Gromaninc.com

Regulatory Flags#

DUNS number
020124663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817494020007EtchmasterEM-L-K-CAEM-L-K-CA2016-09-27
00817494020014EtchmasterEM-L-K-RBEM-L-K-RB2016-09-27
00817494020045EtchmasterEM-L-R-RBEM-L-R-RB2016-09-27
00817494020052EtchmasterEM-S-R-RBEM-S-R-RB2016-09-27
00817494020069EtchmasterEM-S-P-RBEM-S-P-RB2016-09-27
00817494020076EtchmasterEM-S-B-RBEM-S-B-RB2016-09-27
00817494020083EtchmasterEM-L-B-RBEM-L-B-RB2016-09-27
00817494020090EtchmasterEM-S-G-RBEM-S-G-RB2016-09-27
00817494020106EtchmasterEM-L-G-RBEM-L-G-RB2016-09-27
00817494020113EtchmasterEM-S-Y-RBEM-S-Y-RB2016-09-27
00817494020120EtchmasterEM-L-Y-RBEM-L-Y-RB2016-09-27
00817494020137EtchmasterEM-S-J-RBEM-S-J-RB2016-09-27
00817494020144EtchmasterEM-L-N-RBEM-L-N-RB2016-09-27
00817494020151EtchmasterEM-L-F-RBEM-L-F-RB2016-09-27
00817494020168EtchmasterEM-S-O-RBEM-S-O-RB2016-09-27
00817494020175EtchmasterPM-X-L-RBPM-X-L-RB2016-09-27
00817494020038EtchmasterEM-S-K-CAEM-S-K-CA2016-09-27
00817494020694SafetyNebAM-NEB-FP2023-03-01
00817494020700SafetyO2AM-OXY-FP2023-03-01
10817494020691SafetyNebAM-NEB-FP2023-03-01

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